Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Eye Diseases

Rare Diseases

Recurrence

Melanoma

Uveal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Eye Neoplasms

Uveal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Trametinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)

Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Pharmacological Study

Uprosertib

Alexander Shoushtari

This randomized phase II trial studies how well trametinib with or without Akt inhibitor GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective with or without GSK2141795 in treating patients with metastatic uveal melanoma.

PRIMARY OBJECTIVES:

I. To compare progression-free survival between those treated with trametinib alone and those treated with the combination of trametinib and GSK2141795.

SECONDARY OBJECTIVES:

I. To compare overall survival between those treated with trametinib alone and those treated with the combination of trametinib and GSK2141795.

II. To compare the overall response rate between those treated with trametinib alone and those treated with the combination of trametinib and GSK2141795.

III. To compare the safety and toxicity between those treated with trametinib alone and those treated with the combination of trametinib and GSK2141795.

TERTIARY OBJECTIVES:

I. To assess clinical outcomes (response rate, progression-free and overall survival) with trametinib and GSK2141795 after progression on trametinib.

II. To assess toxicity with trametinib and GSK2141795 after progression on trametinib.

III. To correlate clinical outcome with Gnaq/11 mutational status. IV. To assess the pharmacodynamic effects of trametinib alone and with GSK2141795, and utilize whole-transcriptome and reverse phase protein array to identify markers of sensitivity and primary resistance to trametinib alone and with GSK2141795.

V. To assess for changes in circulating tumor deoxyribonucleic acid (DNA) with therapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)

ARM B: Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then every 12 weeks thereafter.

Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma

A Randomized Two-Arm Phase II Study of Trametinib Alone and in Combination With GSK2141795 in Patients With Advanced Uveal Melanoma

Association between suppression and response to treatment will be assessed using Fisher's exact test.

The numeric data will be summarized by clinical response.

Clinical response will be associated with Gnaq/11 mutational status using Wilcoxon rank sum test.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Graded according to the National Cancer Institute CTCAE v4.0. Please see AE/SAE Section for specifics.

OS curves will be generated using Kaplan-Meier methodology.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.

National Cancer Institute (NCI)

AE's and SAE's for Arm A, Arm B, and the crossover group were collected.

Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Trametinib: Given PO

Arm A (Trametinib)

Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Trametinib: Given PO

Uprosertib: Given PO

Arm B (Trametinib, Akt Inhibitor GSK2141795)

Participants had progression of disease on Arm A and were then treated on Arm B.

Crossover Arm

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Alexander Shoushtari

This assessment corresponds to the participants' initial treatment assignment.

Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST

Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent

Overall Survival (OS) Per RECIST Criteria

Partial Response

Progression of Disease

Stable Disease

Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria

The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set.

Change in Apoptosis in Paired Samples as Assessed by Caspase 3 Cleavage

Change in Suppression of Phosphorylated (p)-ERK, AKT, and Cyclin-D1

Data were not analyzed due to lack of funding.

Circulating Tumor DNA Levels

Analysis across the sample set unable to be completed due to patient-specific issues (participants skipped biopsy for safety, insufficient cores for extra DNA extraction)

Gnaq/11 Mutational Status

Overall Study

Antibodies

Immunoglobulins

Immunotoxins

Glembatumumab vedotin

Immunoconjugates

Antibodies, Monoclonal

Immunologic Factors

Antineoplastic Agents, Immunological

Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.

Glembatumumab Vedotin

Sapna Patel

This phase II trial studies how well glembatumumab vedotin works in treating patients with middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the body (metastatic) or has returned at or near the same place after a period of time during which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink the tumor by binding to tumor cells and delivering tumor-killing substances to them.

PRIMARY OBJECTIVES:

I. To characterize the clinical anti-tumor activity of CDX-011 (glembatumumab vedotin) as a single-agent in the treatment of patients with metastatic uveal melanoma.

SECONDARY OBJECTIVES:

I. Description of the clinical safety and benefit of CDX-011 (glembatumumab vedotin) and pharmacodynamics changes in glycoprotein NMB (glycoprotein \[transmembrane\] NMB) (GPNMB) expression.

TERTIARY OBJECTIVES:

I. Characterization of the anti-tumor immunophenotype of patients receiving treatment.

II. Post hoc, correlation of rash with clinical benefit, or lack of rash with lack of benefit, will also be explored.

OUTLINE:

Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma

A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions

Target protein expression change from baseline to after 1 cycle of treatment.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Toxicity will be reported by type, frequency, and severity. Only adverse events toxicity with grade 3-4 severity.

Overall survival as measured from time of enrollment to time of death due to any cause.

Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.

Glembatumumab Vedotin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Treatment (Glembatumumab Vedotin)

Dr. Sapna Pradyuman Patel,MD/ Melanoma Medical Oncology

Disease Progression

Unknown

participants who entered study and received treatment

Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1

Of 32 enrolled participants, 26 had baseline tissue available and 24 had Day 21 tissue available leaving only 22 evaluable for the secondary outcome measure: change in tumor expression from baseline to Day 21. In other words, only 22 participants had tumor collected for both baseline and Day 21 GPNMB expression.

The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry

37 participants signed consent 1 participant withdrew consent for survival follow up

Progression-free Survival

Neutropenia

Thrombocytopenia

Diarrhea

Constipation

Vomiting

Rash, maculopapular

Pruritus

Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0

Overall Survival

Melanoma, Cutaneous Malignant

Disease Attributes

Vaccines

Patients receive epacadostat PO BID on days 1-98 and receive MELITAC 12.1 peptide vaccine ID/SC on days 21, 28, 35, 56, 77, and 98 for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.

Epacadostat

MELITAC 12.1 Peptide Vaccine

Craig Slingluff

This pilot phase II trial studies how well epacadostat and vaccine therapy work in treating patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from peptides and antigens may help the body build an effective immune response to kill tumor cells. Giving epacadostat with vaccine therapy may be an effective treatment for advanced melanoma.

PRIMARY OBJECTIVES:

I. To determine the extent to which a regimen of INCB024360 (epacadostat) that normalizes serum kynurenine (Kyn)/ tryptophan (Trp) ratios alters the tumor microenvironment of melanoma, including determining the number and character of tumor-infiltrating lymphocytes as determined by examination of serial biopsies with immunohistochemistry (IHC) and gene signatures.

II. To determine the extent to which continued INCB024360 treatment plus the addition of the multipeptide melanoma vaccine, MELITAC 12.1 (MELITAC 12.1 peptide vaccine), further alters the tumor microenvironment of melanoma, including determining the number and character of tumor-infiltrating lymphocytes as determined by serial biopsies evaluating IHC and gene signatures.

SECONDARY OBJECTIVES:

I. To determine whether a regimen of INCB024360 that normalizes serum Kyn/Trp ratios plus MELITAC 12.1 vaccine changes the level or character of the vaccine-induced clusters of differentiation (CD) 8+ and CD4+ T-cell immune responses as measured in peripheral blood, as compared to prior published experience.

II. To evaluate the extent to which INCB024360 plus MELITAC 12.1 vaccine alters the number and character of peripheral blood mononuclear cell (PBMC) populations, including T and natural killer (NK) cells, as evaluated by multiparameter flow cytometry.

III. To evaluate the extent to which INCB024360 plus MELITAC 12.1 vaccine alters the PBMC transcriptome.

IV. To assess the safety and tolerability of INCB024360 plus MELITAC 12.1 vaccine.

V. To obtain preliminary data on the tumor response rate of INCB024360 plus MELITAC 12.1 vaccine by objective response rate (ORR), time to tumor progression, and overall survival.

VI. To associate any observed changes with the expression of IDO1 protein by IHC in tumor or tumor-infiltrating cells.

OUTLINE:

Patients receive epacadostat orally (PO) twice daily (BID) on days 1-98 and receive MELITAC 12.1 peptide vaccine intradermally (ID)/subcutaneously (SC) on days 21, 28, 35, 56, 77, and 98. Treatment with epacadostat may repeat every 98 days for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year.

Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma

A Phase II Pilot Trial of an Indoleamine 2,3, Dioxygenase-1 (IDO1) Inhibitor (INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients With Advanced Melanoma

Immunohistochemistry: Tumors were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.

Immunohistochemistry: Tumors (day 21 \& day 42) were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.

Analysis of PBMC gene signature. This may be compared to immunologic response, tumor biopsy data and clinical response

Assessment of immunologic response will be based on a fold-increase measure from baseline as well as using a positivity threshold

Incyte Corporation

University of Virginia

Fred Hutchinson Cancer Center

Principal Investigator

Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1

Cohort A

Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1

Cohort B

Pts. enrolled who have not been treated with check point inhibition

* 100 mg INCB024360 po bid continuous for 98 days
* MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98

Laboratory Biomarker Analysis: Correlative studies

All Other Patients

Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1 INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98

Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1

* INCB024360 - 100 mg po bid continuous for 98 days
* MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98

All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98

Age calculated between time of consent and date of birth.

Age, Categorical

Dr. Martin A. Cheever

Pts.enrolled \>6 wks after failing anti-PD-1/PDL-1

Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 \& 98

Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1

Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 \& 98

All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria

Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 \& 98

For one subject in cohort A day 21 tumor biopsy material was not obtained (For analysis of Cohort A n = 1). For analysis of Cohort "All Other Patients" n = 7 due to day 21 biopsy not being obtained in 2 other subjects. In addition, for one of those subjects there was no baseline tumor biopsy obtained.

Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios.

Neither subject in cohort A had day 42 tumor biopsy material available. For analysis of Cohort "All Other Patients" n = 6 due to either a day 21 biopsy missing or a missing day 42 biopsy.

Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios in Combination With MELITAC 12.1

Change in PBMC Transcriptome_v2

Change in the Number and Character of PBMC Populations, Including T and NK Cells, as Evaluated by Multiparameter Flow Cytometry_v2

Changes in Expression of IDO1 Protein by IHC in Tumor or Tumor-infiltrating Cells_v2

Changes in the Level or Character of the Vaccine-induced CD8+ and CD4+ Specific T-cell Immune Responses by IFN-gamma ELISPOT_v2

Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0_v2

Overall Response Rate Using the RECIST or Immune-Related Response Criteria (irRC)_v2

Overall Survival_v2

Time to Tumor Progression Using RECIST or irRC_v2

Cohort A - Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days All other pts. - received 300 mg po BID

All pts received MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98

Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days

Ocular Melanoma

Imidazole

Temozolomide

Dacarbazine

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cabozantinib S-malate

Jason J Luke

This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.

PRIMARY OBJECTIVES:

I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib-s-malate (cabozantinib) or temozolomide (or dacarbazine).

SECONDARY OBJECTIVES:

I. Estimate the distribution of progression-free survival (PFS) times. II. Estimate the distribution of overall survival (OS) times. III. Estimate the confirmed response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

IV. Assess the safety of these agents by examining the toxicity profile. V. Correlate the response of MET molecular status.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine intravenously (IV) over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for 2 years.

Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery

Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.

A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patients. A one-sided chi-squared test for a difference in PFS4 proportions will be used to test for a difference between arms.

The confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.

percentage of patients who experienced grade 3+ adverse events regardless of attribution, graded according to the National Cancer Institute CTCAE version 4.0

The distribution of OS time will be estimated using the method of Kaplan Meier.

The distribution of PFS time will be estimated using the method of Kaplan Meier and is defined as the number of days from registration until disease progression (or death). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Exelisis

Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm I (Cabozantinib-s-malate)

Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm II (Temozolomide)

Patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Dacarbazine)

Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \>\>

\>\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Temozolomide or Dacarbazine)

Canada

All participants that began study treatment are included in the baseline analysis.

Jason J. Luke, M.D.

A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.

Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

\>

\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

All patients that began protocol treatment were included in this analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma	NCT01979523	Recurrent Uveal... Stage IV Uveal ...	Laboratory Biom... Pharmacological... Trametinib Uprosertib	18 Years -	National Cancer Institute (NCI)
Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma	NCT02363283	Recurrent Uveal... Stage IV Uveal ...	Glembatumumab V... Laboratory Biom... Pharmacological...	18 Years -	National Cancer Institute (NCI)
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma	NCT01961115	Mucosal Melanom... Recurrent Melan... Recurrent Uveal... Stage IIIA Skin... Stage IIIA Uvea... Stage IIIB Skin... Stage IIIB Uvea... Stage IIIC Skin... Stage IIIC Uvea... Stage IV Skin M... Stage IV Uveal ...	Epacadostat MELITAC 12.1 Pe...	18 Years -	Fred Hutchinson Cancer Center
Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery	NCT01835145	Recurrent Uveal... Stage III Uveal... Stage IIIA Uvea... Stage IIIB Uvea... Stage IIIC Uvea... Stage IV Uveal ...	Cabozantinib S-... Dacarbazine Laboratory Biom... Temozolomide	18 Years -	National Cancer Institute (NCI)
Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma	NCT02363283	Recurrent Uveal... Stage IV Uveal ...	Glembatumumab V... Laboratory Biom... Pharmacological...	18 Years -	National Cancer Institute (NCI)
Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma	NCT01979523	Recurrent Uveal... Stage IV Uveal ...	Laboratory Biom... Pharmacological... Trametinib Uprosertib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for recurrent uveal melanoma